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Manufacturers
bioMerieux
Manufacturer Address
bioMerieux, 100 Rodolphe Street, Building 1300, Durham NC 27712
Source
USFDA
4 Events
Recall of VIDAS
Recall of Device Recall VIDAS CMV IgG
Recall of Device Recall MDA Simplastin L
Recall of Device Recall Simplastin L
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4 devices in the database
VIDAS
Model / Serial
Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA
Product Description
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use || Product Number: 30101
Device Recall VIDAS CMV IgG
Model / Serial
Catalog #30 204, Lot #782887501
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.
Product Description
VIDAS¿ CMV IgG Assay
Device Recall MDA Simplastin L
Model / Serial
Product #252555, Lot #500065, 500066 and 500067
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
Product Description
MDA¿ Simplastin¿ L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.
Device Recall Simplastin L
Model / Serial
Product #259553, Lot #161642, 161643 and 161690.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.
Product Description
Simplastin¿ L, Prothrombin Time test, 10 vials (20 ml each), Product Number 259553, bioMerieux,
152 manufacturers with a similar name
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bioMerieux SA
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
TDMDAT
Biomerieux SA
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
TDMDAT
BioMerieux SA
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
TDMDAT
BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
NIDFSINVIMA
BIOMERIEUX FRANCIA || Importer: BIOMERIEUX COLOMBIA LTDA
Manufacturer Parent Company (2017)
Compagnie Merieux Alliance
Source
NIDFSINVIMA
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